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Biomed Outsourcing Report-Opportunities in Outsourcing Marketing, Regulatory and Downstream Services CanBiotech December 2003 Report Code: DecBONSL2003 CDN $ 250 Buy Abstract 33 Pages This report highlights key issues facing the bio-pharmaceutical industry with regard to outsourcing marketing, public relations, branding, regulatory affairs, regulatory submissions including electronic submissions, medical writing and editing, sales, marketing and clinical research staff recruitment, and validation and quality control services. Included is a directory featuring North American regulatory affairs service providers listed on the CanBiotech and BioMedical-Outsourcing Networks. Partnerships to Manage the Product Launch-This article discusses the role that public relations companies can play in the product launch. Public relations (PR) companies can assist pharmaceutical companies to be perceived more positively and as sources of reliable information regarding their products. Such firms can create momentum for a product during clinical trials and patient recruitment and then augment a client’s marketing and sales effort after market approval. The Role of Branding in the Pharmaceutical Industry-In this article, RNCOS discusses the importance of branding to the industry, the process of brand development, and the concept of brand protection. Building Effective Relationships with Patient Advocacy Groups-This article discusses the value of partnering with patient advocacy groups during clinical trial development, the drug approval process, product positioning and market creation. The role of public relations companies in assisting in the formation of such partnerships is discussed in this article. Outsourcing to Regulatory Affairs Professionals to Manage Global Approvals-This article discusses how regulatory affairs professionals can better enable bio-pharmaceutical companies manage the approval process in a rapidly changing regulatory environment. Regulatory Submissions and Global Harmonization-This article outlines critical issues facing the industry including: Paper versus electronic submission, region-specific requirements for submission, the e-CTD and mixtures of paper and electronic submissions, XML-based standards for data structure and presentation, compliance with 21 CFR Part 11-issues that may warrant partnering with experts in these arenas. Fulfilling the Need for Objective Medical Writing and Editing in Scientific Communications-In this article, MedBio Publications discusses how a medical writing/editing firm can meet the scientific communication needs of a bio-pharmaceutical client. Identifying the Best Candidates for Sales, Marketing and Clinical Research-In this article, Jim Gray of Rockwall Management Consulting discusses how outsourcing some HR functions can improve the bottom line as well as productivity within an HR department. Outsourcing Validation and Quality-Control Services-In this article, the need for outsourcing these services given the current regulatory environment, the types of services that can be outsourced, the process for making the decision to outsource, the selection of the service provider and the management of a partnership are discussed. Table of Contents Click here to view the Table of Contents

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